The following data is part of a premarket notification filed by Sensortek, Inc. with the FDA for Esophageal Stetho Scope.
| Device ID | K844055 |
| 510k Number | K844055 |
| Device Name: | ESOPHAGEAL STETHO SCOPE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | SENSORTEK, INC. 154 HURON AVE. Clifton, NJ 07013 |
| Contact | Ronald R Feller |
| Correspondent | Ronald R Feller SENSORTEK, INC. 154 HURON AVE. Clifton, NJ 07013 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-18 |
| Decision Date | 1984-10-25 |